Quality Assurance Engineer

Country: Denmark

Location: Ballerup, DK

City: Ballerup

Business Area: QA/RA

Employment type: Full-time

Quality Assurance Engineer

Are you ready to make a significant impact in the healthcare market? Do you thrive in a collaborative, international environment where innovation is at the forefront? Then we may have the right position for you!

Ambu A/S is on the lookout for a dynamic Quality Assurance Engineer to be a key player in our Corporate QAE Team. Reporting into the Head of QAE Compliance and SQM team, you will join our dedicated Corporate QAE Team, consisting of 9 other brilliant minds and diverse personalities.

You will play an active role on keeping our global complaint processes efficient and well implemented and you will be responsible for trending of complaints. You will be a part of an international environment and collaborate globally with many colleagues across Ambu sites.

Key responsibilities

Your main responsibilities will include:

• Cultivate and enhance the Complaint Trending and Monitoring process.
• Generate insightful trending reports that guide strategic decisions.
• Bolster the complaint handling process, overseeing a spectrum of complaint-related tasks.
• Engage actively in internal audits and collaborate seamlessly during inspections by external authorities.
• Offer robust support and contribute proactively to various process activities within the Corporate QA organization.

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you possess:

• Proven experience in the customer complaint process, data trending, and post-market feedback.
• A Bachelor's or Master's degree in Engineering or a related discipline.
• Over 2 years of pertinent professional experience in quality assurance within the medical device industry.
• Proficiency in business intelligence and statistics.
• Familiarity with Quality Assurance for medical devices, including EU MDR, ISO 13485, and 21 CFR Part 820.
• Effective collaboration, strong communication, and analytical skills, alongside a steadfast commitment to quality.
• Driven by personal motivation, your fluency in English enables seamless interaction within our innovative and international environment.

Ambu – a visionary and international workplace where your efforts matter
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.